Senior Director, CMC

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🕒 Junho 2

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Allucent

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A Allucent é um parceiro de referência para empresas de biotech de pequeno e médio porte, oferecendo soluções inovadoras em assuntos regulatórios e desenvolvimento clínico. Com mais de 30 anos de experiência, a Allucent é especializada em expertise terapêutica, farmacologia clínica, estratégia regulatória, segurança de medicamentos e nos processos de farmacovigilância necessários para levar novas terapias ao mercado. Seus serviços abrangentes abordam desafios desde a descoberta de fármacos em fases iniciais até os ensaios clínicos e a vigilância pós-comercialização, apoiando diversas áreas terapêuticas, como oncologia, doenças infecciosas, neurologia, doenças autoimunes e doenças raras. O compromisso da Allucent em fomentar ciência de ponta ajuda as empresas de biotech a navegar pelas complexidades do desenvolvimento de medicamentos de forma eficiente e eficaz.

Descrição

• At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. • As the Sr. Director, CMC, you will: • - **Lead end-to-end CMC strategy** across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects. • - **Drive regulatory excellence** by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines. • - **Prepare product development plans** from early development through Phase 4. • - **Manage and lead direct reports** through development and performance management and by providing training on current and new regulatory requirements. • - **Perform other scientist related duties**, as needed.

🎯 Requisitos

• - Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development • - Advanced scientific and regulatory knowledge of drug, biologic, or device development • - Experience in pre-approval products; large biologics experience required. • - Line management experience required. • - Prior CRO experience preferred. • **Skills:** • - Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, strong written and verbal communication skills in English • - Strong computer skills, including SharePoint, Word, Excel, and PowerPoint • - Quality focus • - Strong emotional intelligence, customer focused leadership and decision-making skills • - Innovative, creative, and practical thinking including problem-solving skills • - >10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

🏖️ Benefícios

• **Benefits of working at Allucent include:** • - Comprehensive benefits package per location • - Competitive salaries per location • - Departmental Study/Training Budget for furthering professional development • - Flexible Working hours (within reason) • - Opportunity for remote/hybrid* working depending on location • - Leadership and mentoring opportunities • - Participation in our Buddy Program as a new or existing employee • - Internal growth opportunities and career progression • - Financially rewarding internal employee referral program '